The document summarizes the results of an industry survey on the future of pre-filled syringes. According to the survey, experts believe the biggest problems currently facing the pre-filled syringe industry are materials questions, difficulty preventing leachables and extractables into drug products, and usability from a patient focus. When asked about regulatory factors, experts highlighted new FDA guidelines for combination products and the interpretation of analytical results. A majority of respondents believed the future of development lies with plastic syringes rather than glass. The biggest advancements in the pre-filled syringe industry were seen as attaining high patient safety in self-administration and meeting changing therapeutic demands.

1. INDUSTRY SURVEY RESULTS
WHAT ARE INDUSTRY PROFESSIONALS SAYING ABOUT THE FUTURE OF PRE-FILLED SYRINGES?
WHAT DO YOU BELIEVE TO BE THE BIGGEST
PROBLEMS CURRENTLY FACING THE PFS
INDUSTRY
Materials questions
Difficulty in prevention of
L&E into drug products
Threshold on
biological products
- are becoming too
viscous for current
technologies
Usability from
patient focus
32.9%
12.95%
Lack of uptake from major
industry eg. the NHS
WHAT DO YOU FIND TO BE THE MOST
IMPORTANT IN REGULATORY FACTORS
Updates on task
force initiates
5.18%
12.15%
32.00%
We asked leading experts their thoughts on the challenges
that the industry faces today and the opportunities for this
rapidly expanding sector, ahead of the Pre-Filled Syringes
Conference 2014.
21.22%
21.68%
*Some other answers include
• imited flexibility in PFS designs
L
(volumes etc) particularily in
relation to weight based dosing
• Short Shelf Life
• Cost vs volume
• Stability data
Other*
ABOUT THE SURVEY
Pre-filled syringes are emerging as a huge growth segment
in the pharma industry, analysts predict it to reach $3.9bn
by 2015. This growth has triggered a wave of innovation in
injectables technology. Pharma companies world-wide are
now launching and converting products in the pre filled
market.
Interpretation of
analytical results
16.04%
New FDA
guidelines in
combination
products
45.88%
• igh cost of disposable auto
H
injectors due to poor
syringe standardization etc
• oor adherence and storage
P
by the users
Pre-Filled Syringes
Future applications for safer drug delivery
Marriot Regents Park Hotel, London, UK
PLASTIC VS GLASS: WHERE
DO YOU THINK THE FUTURE
DEVELOPMENT LIES
76.24%
WHAT DO YOU BELIEVE TO BE THE BIGGEST
ADVANCEMENTS RECENTLY WITH THE PFS
INDUSTRY
11.69%
Other*
Why glass:
• More neutral vs content
• Is less of an issue with LE
• Better quality
• Product stability
Why plastic:
• Low weight
(lower transportation costs)
• High robustness
• Tighter dimensions
• No breakage during filling procedure
• Compatibility with devices (e.g.
needle-free valves, pumps)
• Less safety issues, more control
• No silicone required
Plastic
Glass
23.76%
Attaining
high patient
safety in selfadministration
Meeting
changing
therapeutic
demands
6.90%
27.59%
41.38%
13.79%
*Some other answers include
• septic filling optimization
A
• he increasing need to perform Human Factor Studies
T
• ntroduction of thinner needles
I
Advancements
in needle free
administration
Advancements
in drug stability
issues and
prevention of
leachables and
extratables
27th - 28th
JAN
2014
Now in its 6th year, the 2014 conference from the SMi
Group will bring together experts from a range of industry
perspectives to discuss solutions and strategies within key
issues such as syringe formulations for biosimilars and other
biologics, extractables and leachables, primary packaging
developments and filling and finishing.
Based on the online Pre-Filled Syringes Survey, of more
than 55 senior executives involved in the PFS Sector from
companies based in Europe and the USA, conducted by the SMi
Group in August-October 2013. This information is accurate
to the best of the respondents knowledge at that time, and
may subsequently have changed. The SMi Group cannot take
responsibility for the accuracy of this information.
For more information please visit www.pre-filled-syringes.com